Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

lntravascular Administration Sets with Stopcock and Manifold

K-Number: K223175 · 2023-03-10

ApplicantBaxter Healthcare Corporation
Decision Date2023-03-10
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

lntravascular Administration Sets with Stopcock and Manifold is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K223175. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the lntravascular Administration Sets with Stopcock and Manifold?

lntravascular Administration Sets with Stopcock and Manifold is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K223175.

When did lntravascular Administration Sets with Stopcock and Manifold receive FDA 510(k) clearance?

lntravascular Administration Sets with Stopcock and Manifold received FDA 510(k) clearance on 2023-03-10, under 510(k) number K223175.

Who is the listed applicant for lntravascular Administration Sets with Stopcock and Manifold?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for lntravascular Administration Sets with Stopcock and Manifold?

The FDA product code for lntravascular Administration Sets with Stopcock and Manifold is FMG.

Other records listing Baxter Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P210036Agent, absorbable hemostatic, non-collagen basedK251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)PMA P990009Absorbable collagen hemostatic agent with thrombinK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)PMA P100030Sealant, polymerizing

View all 53 devices →

Related Devices (Code: FMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242255Qitexio® 4-Way Stopcock (QIT014)MedexK223499Three Way Stop CockM/S Romsons InternationalK211204SafePort(TM) Manifold (or Stopcock)Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLCK190489Elcam Stopcocks and ManifoldsElcam Medical Acal

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑